Pilonidal SinusNCT02539693
Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery
A study testing Clonidine 75 µg/mL in sacrococcygeal block, Clonidine 150 µg/mL in sacrococcygeal block and Lidocaine in people with Pilonidal Sinus, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Sacrococcygeal local anesthesia was shown to reduce the time spent in the operating room as well as in the recovery room. In addition, decreased hospital stay and postoperative analgesic consumption. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- Clonidine 75 µg/mL in sacrococcygeal block, Clonidine 150 µg/mL in sacrococcygeal block and Lidocaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- Oct 2016to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for pilonidal sinus surgery
Who cannot join
- Patients who have allergic reactions to lidocaine
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Makassed General Hospital
Beirut
Zoher Naja, MD, +9611636000 ext. 6405, zouhnaja@yahoo.com
About this study
Official title: Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery: A Prospective Randomized Trial
Sacrococcygeal local anesthesia was shown to reduce the time spent in the operating room as well as in the recovery room. In addition, decreased hospital stay and postoperative analgesic consumption.
Given the effectiveness of sacrococcygeal local anesthesia in pilonidal sinus surgery, it would be valuable to study the effect of the local anesthesia with 75µg/mL of clonidine versus 150µg/mL.
Read the detailed description
Study design and sampling
This is a prospective study with a randomized double-blind design that will be conducted between October 2015 and October 2016.
Patients scheduled for pilonidal sinus surgery will be included. Patients will be randomly distributed to one of 2 groups with 30 patients in each, using the sealed envelope technique. Group one will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine, while group two will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine.
Anesthetic techniques
Being a double-blinded study, a specialized nurse will prepare the syringes for each patient.
Sacrococcygeal local anesthesia technique
The Sacrococcygeal block will be performed with the patient in the prone position. Four injection sites are marked on the skin after aseptic preparation.
The sites are placed as follows: 4 cm below and above the pilonidal sinus and 3 cm lateral to its center on both sides. Therefore a "lozenge" is formed by connecting the 4 sites.
At first, an injection of 0.3 ml lidocaine 1% is injected at each site using an 8-mm 30G needle. Then 4 injections are admitted to each of the 4 injection sites in turn, with equal supply of the anesthetic mixture in the following manner: a 10-mm 27G needle containing the anesthetic mixture is introduced perpendicularly to the skin and the mixture is infiltrated. The needle is partially withdrawn and reinserted at 45 degrees to the skin aiming towards the center of the pilonidal sinus and an injection will be performed. Then the needle is partially withdrawn again and reinserted at an angle of 45 degrees to the skin aiming at one side of the lozenge then at the other side where injections are done.
In case of a multiple pilonidal orifices, a hexagon is done. These sites are then anesthetized as previously described.
Anesthetic mixture
For group 1, the syringe will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL).
As for group 2, the syringes will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL).
Depending on each patient's weight and type of pilonidal sinus, the anesthetic mixture might vary from 30 to 40 mL in total.
Data collection
Demographic data, type and duration of surgery will be recorded. Haemodynamics will be registered at all times (pre-operatively, intra-operatively and post-operatively).
Pain will be assessed using VNRS with 0 being no pain and 10 maximum pain for 48 hours post-operatively.
As for postoperative analgesia consumption, patients with a VNRS score less than 3 are given paracetamol 1000 mg each 8 hours. If VNRS is between three and four, patients are given Tramadol Hydrochloride 50-100 mg every 4- 6 hours and if the VNRS score is greater or equal to five, patients receive 1 mg/kg Dolosal.
Return to normal activity will be defined by the ability to sit, walk and work comfortably and will be assessed by calling the patients.
- Conditions
- Pilonidal Sinus
- Being tested
- Clonidine 75 µg/mL in sacrococcygeal block, Clonidine 150 µg/mL in sacrococcygeal block, Lidocaine, Pilonidal sinus
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonidine 75 µg/mL in sacrococcygeal blockDrug
Sacrococcygeal block will be performed using 75 µg/mL clonidine in the anesthetic mixture
Clonidine 150 µg/mL in sacrococcygeal blockDrug
Sacrococcygeal block will be performed using 150 µg/mL clonidine in the anesthetic mixture
LidocaineDrug
3 ml lidocaine 1% is injected at each block site
Pilonidal sinusProcedure or surgery
Removal of pilonidal sinus
| Study group | Role | What they receive |
|---|---|---|
| Clonidine 75 | Experimental | Patients will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL). Receives: Drug: Clonidine 75 µg/mL in sacrococcygeal block; Drug: Lidocaine; Procedure: Pilonidal sinus |
| Clonidine 150 | Experimental | Patients will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL). Receives: Drug: Clonidine 150 µg/mL in sacrococcygeal block; Drug: Lidocaine; Procedure: Pilonidal sinus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare analgesic consumption using questionnaire
Measured: Patients will be followed-up after the operation, an expected average of five days
Secondary outcomes (2)
Time needed to return to normal activity noted by calling the patients
Measured: Patients will be followed-up after the operation, an expected average of five days
Pain using verbal numeric rating scale (VNRS)
Measured: Patients will be followed-up after the operation, an expected average of five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startOct 2016
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoher Naja, Makassed General Hospital
- Investigators
- Zoher Naja, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539693
- Sponsor's protocol ID
- 082015
- Status last verified
- Jan 2022
- First submitted
- 1 Sep 2015
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02539693
- Acronym / sponsor ID
- 082015
- Conditions
- Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sacrococcygeal local anesthesia was shown to reduce the time spent in the operating room as well as in the recovery room. In addition, decreased hospital stay and postoperative analgesic consumption.
Given the effectiveness of sacrococcygeal local anesthesia in pilonidal sinus surgery, it would be valuable to study the effect of the local anesthesia with 75µg/mL of clonidine versus 150µg/mL.
Detailed description
Study design and sampling
This is a prospective study with a randomized double-blind design that will be conducted between October 2015 and October 2016.
Patients scheduled for pilonidal sinus surgery will be included. Patients will be randomly distributed to one of 2 groups with 30 patients in each, using the sealed envelope technique. Group one will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine, while group two will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine.
Anesthetic techniques
Being a double-blinded study, a specialized nurse will prepare the syringes for each patient.
Sacrococcygeal local anesthesia technique
The Sacrococcygeal block will be performed with the patient in the prone position. Four injection sites are marked on the skin after aseptic preparation.
The sites are placed as follows: 4 cm below and above the pilonidal sinus and 3 cm lateral to its center on both sides. Therefore a "lozenge" is formed by connecting the 4 sites.
At first, an injection of 0.3 ml lidocaine 1% is injected at each site using an 8-mm 30G needle. Then 4 injections are admitted to each of the 4 injection sites in turn, with equal supply of the anesthetic mixture in the following manner: a 10-mm 27G needle containing the anesthetic mixture is introduced perpendicularly to the skin and the mixture is infiltrated. The needle is partially withdrawn and reinserted at 45 degrees to the skin aiming towards the center of the pilonidal sinus and an injection will be performed. Then the needle is partially withdrawn again and reinserted at an angle of 45 degrees to the skin aiming at one side of the lozenge then at the other side where injections are done.
In case of a multiple pilonidal orifices, a hexagon is done. These sites are then anesthetized as previously described.
Anesthetic mixture
For group 1, the syringe will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL).
As for group 2, the syringes will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL).
Depending on each patient's weight and type of pilonidal sinus, the anesthetic mixture might vary from 30 to 40 mL in total.
Data collection
Demographic data, type and duration of surgery will be recorded. Haemodynamics will be registered at all times (pre-operatively, intra-operatively and post-operatively).
Pain will be assessed using VNRS with 0 being no pain and 10 maximum pain for 48 hours post-operatively.
As for postoperative analgesia consumption, patients with a VNRS score less than 3 are given paracetamol 1000 mg each 8 hours. If VNRS is between three and four, patients are given Tramadol Hydrochloride 50-100 mg every 4- 6 hours and if the VNRS score is greater or equal to five, patients receive 1 mg/kg Dolosal.
Return to normal activity will be defined by the ability to sit, walk and work comfortably and will be assessed by calling the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clonidine 75 | Experimental | Drug: Clonidine 75 µg/mL in sacrococcygeal block, Drug: Lidocaine, Procedure: Pilonidal sinusPatients will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL). |
| Clonidine 150 | Experimental | Drug: Clonidine 150 µg/mL in sacrococcygeal block, Drug: Lidocaine, Procedure: Pilonidal sinusPatients will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients scheduled for pilonidal sinus surgery
Key exclusion criteria (1 listed)
- Patients who have allergic reactions to lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidine 75 µg/mL in sacrococcygeal blockSacrococcygeal block will be performed using 75 µg/mL clonidine in the anesthetic mixture | Drug | Clonidine 75 |
| Clonidine 150 µg/mL in sacrococcygeal blockSacrococcygeal block will be performed using 150 µg/mL clonidine in the anesthetic mixture | Drug | Clonidine 150 |
| Lidocaine3 ml lidocaine 1% is injected at each block site | Drug | Clonidine 150, Clonidine 75 |
| Pilonidal sinusRemoval of pilonidal sinus | Procedure or surgery | Clonidine 150, Clonidine 75 |
Primary outcome
Compare analgesic consumption using questionnaire
Time frame: Patients will be followed-up after the operation, an expected average of five days
2 secondary outcomes
Time needed to return to normal activity noted by calling the patients
Time frame: Patients will be followed-up after the operation, an expected average of five days
Pain using verbal numeric rating scale (VNRS)
Time frame: Patients will be followed-up after the operation, an expected average of five days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoher Naja, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clonidine 75 µg/mL in sacrococcygeal block, Clonidine 150 µg/mL in sacrococcygeal block and Lidocaine in people with Pilonidal Sinus, run by Makassed General Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoher Naja, MD (+9611636000 ext. 6405, zouhnaja@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare analgesic consumption using questionnaire (time frame: Patients will be followed-up after the operation, an expected average of five days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.